Strain-Counterstrain Treatment of Piriformis Pain

The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Mechanical; Piriformis Syndrome; Somatic Dysfunction of Sacral Region (Finding)
• Intervention / Treatment: Other: Strain-Counterstrain treatment of piriformis muscle

Detailed Description

There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle.

There will be two treatments, 1-2 weeks apart ideally.

Participants will fill out the Oswestry Disability Index Questionnaire before the first treatment and after the second treatment (which is 1-2 weeks after the first treatment).

Participants will also identify pain using the Visual Analog Scale (VAS) before and after each treatment. Participants will identify pain at rest prior to treatment using VAS. Participant will then identify pain at the start of treatment while pressure is applied to the piriformis muscle (4.5kg/cm2) and post treatment while pressure is applied to the piriformis muscle (4.5 kg/cm2).

An algometer will be used pre and post each treatment (2 treatments that are 1-2 weeks apart) to objectively measure any change in pain pressure threshold.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roya Vahdatinia, DO; Phone Number: 9095586202; Email: rvahdatinia@llu.edu
• Study Contact Backup: Name: Mickey Lui, DO; Phone Number: 9095586202; Email: Mickey.Lui@va.gov

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Recruiting
      • Loma Linda University health
      • Contact: Mickey Lui, MD; Phone Number: 909-558-1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 to 65 years of age
• Tender point (or trigger point) in piriformis muscle determined by physical exam

Exclusion criteria:

• Less than 45 degrees of active hip flexion, less than 5 degrees of active hip internal rotation or less than 30 degrees of active hip external rotation, on side of affected piriformis
• Unable to lay prone
• Non-English speaker
• Inability to attend 2 sessions within the same month
• Active cancer
• Pregnant
• Diagnosis of lumbar radiculopathy
• Greater than grade 1 lumbar spondylolisthesis
• Presence of lumbar region Pars Defect
• Receiving massage, acupuncture, chiropractic treatments, osteopathic treatments during study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piriformis Strain-Counterstrain; The treatment group will receive strain-counterstrain for the piriformis muscle.	Other: Strain-Counterstrain treatment of piriformis muscle; Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.
Sham Comparator: Hamstring Strain-Counterstrain; The sham group will receive strain-counterstrain treatment for the hamstring muscle.	Other: Strain-Counterstrain treatment of piriformis muscle; Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometer - Change in pressure pain threshold	Objective improvement in pressure/pain threshold	Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale	Subjective improvement in low back/leg pain	Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Change in Oswestry Disability Index	Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living	Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Mickey Lui, Loma Linda University health

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Pelvic Pain; Back Pain; Mononeuropathies; Nerve Compression Syndromes; Sciatic Neuropathy; Pathological Conditions, Signs and Symptoms; Low Back Pain; Piriformis Muscle Syndrome; Signs and Symptoms
• Other Study ID Numbers: 5210286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No